[Hiring] Vice President, Clinical Development @Annexon Biosciences

Role Description

We are seeking an accomplished and visionary leader to join our team as Vice President, Clinical Development-Ophthalmology. The Vice President, Clinical Development-Ophthalmology will play a critical role in shaping and executing our ophthalmology strategy, serve as the clinical leader for Annexon’s ophthalmology portfolio, including late-stage programs such as Vonaprument including data readout, interpretation, communication, submission, approval, and commercialization of vonaprument for the treatment of geographic atrophy. This role requires a seasoned professional with deep expertise in ophthalmology, particularly in retinal diseases, and drug development within this therapeutic area, possessing strong leadership skills, and a track record of success in bringing innovative therapies to market. The Vice President, Clinical Development-Ophthalmology will be responsible for driving the clinical strategic direction of our vonaprument franchise working collaboratively with key team leadership. Like all Annexon leaders, the Vice President, Clinical Development-Ophthalmology incumbent will have a deep-rooted commitment to serving patients and a passion for transforming the lives of people with serious diseases and their families.

Responsibilities

• Lead the medical/clinical oversight of the Phase 3 program including communication with sites throughout the study in collaboration with the Medical Affairs team.
• Review and interpretation of all clinical data, and communication of results in scientific and informal venues.
• Medical authorship and ensuring the integrity and quality of abstracts, manuscripts, study reports, and regulatory communications and documents.
• Serve as the clinical expert developing the life cycle management plan for vonaprument including an open-label extension study, subset identification, extended dosing, and expanded indications.
• Interactions with Key Opinion Leaders to educate and advance the field on the benefit afforded by vonaprument based on its unique mechanism of action.
• Identify core objectives for the design and implementation of the clinical development strategy.
• Represent Annexon and the vonaprument program for external engagements with CRO’s, consultants, sites, etc.
• Oversee the execution of clinical trials in collaboration with Clinical Operations.
• Serve as the Ophthalmology Lead for the development team, partnering closely with various departments.
• Provide the primary authorship for key clinical sections of marketing authorization submissions.
• Provide medical leadership for issue identification/resolution, and data quality.
• Support for business development activities in Ophthalmology.

Strategic Leadership

• Serve as a member of the vonaprument Core Team and Development Leadership Team.
• Leverage scientific and clinical expertise to guide decision-making and optimize execution and data interpretation.
• Leadership role in collaboration with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings.
• Drive innovation and differentiation of vonaprument through understanding of current and future data generated for the program.
• Develop and execute robust regulatory strategies for the program.
• Interface with regulatory authorities to facilitate successful regulatory submissions and approvals.
• Stay abreast of evolving guidelines and requirements for ophthalmic drug development.

Cross-Functional Collaboration

• Foster strong collaboration and alignment across functions, including R&D, clinical development, regulatory affairs, commercial, and other relevant departments.
• Serve as a key liaison between the ophthalmology team and executive leadership.
• Cultivate a culture of teamwork, innovation, and accountability within the ophthalmology organization.

Qualifications

• Medical Degree with subspecialty training and practice in Retina and MD or MD/PhD with deep experience in the field of Ophthalmology required.
• 15 – 20 + years of experience in the pharmaceutical or biotechnology industry, with a focus on ophthalmology drug development.
• Prior experience as a VP in Clinical Development strongly preferred.
• Proven track record of leadership in ophthalmology, including successful development and commercialization of ophthalmology products.
• In-depth understanding of ophthalmic diseases, drug development processes, and regulatory requirements.
• Demonstrated ability to develop and execute strategic plans, drive innovation, and deliver results in a fast-paced, dynamic environment.
• Strong leadership and interpersonal skills, with the ability to inspire and influence teams at all levels of the organization.
• Excellent communication and presentation skills, with the ability to effectively articulate complex scientific and clinical concepts to diverse audiences.
• Experience interacting with regulatory authorities and leading successful regulatory submissions and approvals.
• Business acumen and strategic thinking, with a focus on maximizing the commercial potential of ophthalmology products.

Preferred

• Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting.
• Familiarity with emerging trends in ophthalmology, including cutting-edge therapeutic modalities.

Salary Range

$399,600 – $427,500 USD

Location

Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.

Benefits

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities, and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.